FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
10135-611
11-digit product format
101350611
Labeler code
10135
Product ID
10135-611_da063b55-10e9-4231-9f23-22216f257455
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA204010
Marketing category
ANDA
Marketing start
2016-02-01
Marketing end
0000-00-00
Substance
OXYBUTYNIN CHLORIDE
Active strength
15 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-611-012021-01-29C16284748780-1ba0f9c33-5366-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use oxybutynin chloride extended-release tablets safely and effectively. See full prescribing information for oxybutynin chloride extended-release tablets. OXYBUTYNIN chloride extended-release tablets, USP for oral use. Initial U.S. Approval: 1975

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-611-01Oxybutynin Chloride100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-611-01EA - Each10135-611c3808c66-f29a-4bad-aef1-f7a893496cae12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-611OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC]3Legacy NDC, 1 package rows20191213_301a7fca-c556-4b53-899f-bc7e2a74ded8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN301a7fca-c556-4b53-899f-bc7e2a74ded83
863628oxyBUTYnin chloride 15 MG 24HR Extended Release Oral TabletPSN301a7fca-c556-4b53-899f-bc7e2a74ded83
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN301a7fca-c556-4b53-899f-bc7e2a74ded83
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD301a7fca-c556-4b53-899f-bc7e2a74ded83
86362824 HR oxybutynin chloride 15 MG Extended Release Oral TabletSCD301a7fca-c556-4b53-899f-bc7e2a74ded83
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD301a7fca-c556-4b53-899f-bc7e2a74ded83
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY301a7fca-c556-4b53-899f-bc7e2a74ded83
863628oxybutynin chloride 15 MG 24 HR Extended Release Oral TabletSY301a7fca-c556-4b53-899f-bc7e2a74ded83
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY301a7fca-c556-4b53-899f-bc7e2a74ded83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-611-0110135061101100 in 1 BOTTLE, PLASTICHistorical